(33 days)
RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
The system functionality can be configured based on user needs.
The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
RayStation 6.1 is a radiation therapy treatment planning system, i.e. a software program for planning and analysis of radiation therapy treatment plans. Functionality includes fusion capabilities (CT, PET and MRI), contouring, collapsed cone convolution dose computation and 4D data compatibility, as well as unique features such as multi-criteria optimization, dose tracking, treatment adaptation and deformable registration, all available on one platform.
I'm sorry, but the provided text does not contain any information about acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, ground truth establishment, MRMC studies, or standalone performance testing for a medical device.
The document is a 510(k) premarket notification for a software system called "RayStation 6.1," which is a radiation therapy treatment planning system. It discusses the regulatory approval process, classification, device description, intended use, and a summary of non-clinical performance data, stating that "The summary of the performed non-clinical tests shows that RayStation 6.1 is as safe and effective, and performs as well as the predicate device." However, it does not provide the specific details of these tests or the data results that would be needed to answer your questions.
Therefore, I cannot provide the requested information based on the given input.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.